BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10701480 · Received October 19, 2020

    Report

    Report Number
    3008642652-2018-06097
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    January 31, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS FULLY FUNCTIONAL AND PASSED INCOMING FUNCTIONAL TESTING. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE DEVICE, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY OF THE MONITOR. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS FULLY FUNCTIONAL AND PASSED INCOMING FUNCTIONAL TESTING OF THE DEVICE'S ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY.

    Description of Event or Problem · 1

    ON 10/16/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHERE THE ELECTRONIC 3500A PDF FORM COULD NOT BE LOCATED. THE INTERNAL AUDIT INDICATES THAT THE ELECTRONIC 3500A FORM, WITHIN THE ESUBMITTER APPLICATION, WAS CREATED ON 07/12/2018. ACKNOWLEDGEMENTS 1, 2, AND 3 COULD NOT BE LOCATED. A US DISTRIBUTOR CONTACTED ZOLL AND REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2018 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF PASSING. BETWEEN 03:17:34 AND 03:23:00 ON (B)(6) 2018 THE PATIENT DEGRADED FROM A SINUS RHYTHM AT 70 BPM TO ASYSTOLE AND THEN TO VF. THE PATIENT WAS IN VF FOR 40 SECONDS BEFORE SELF-CONVERTING TO AN ACCELERATED IDIOVENTRICULAR RHYTHM (50-80 BPM). VARYING AMPLITUDE OF THE VF SIGNAL AND MOTION ARTIFACT PREVENTED THE LIFEVEST FROM TREATING THE ARRHYTHMIA. THE PATIENT THEN DEGRADED TO SEVERE BRADYCARDIA AT 10 BPM AND THE DEVICE WAS DEACTIVATED AT 03:23:05 ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159875 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death